Job Description

Responsibilities: Managing the process development activities required to develop, scale up, optimize, and transfer well understood robust manufacturing processes for solid oral dosage forms. Operation of GMP manufacturing suites with a broad range of processing capability and technology approaches. Provide Subject Matter Expert understanding of the operation of processing equipment with ability to assimilate and use new technologies quickly and provide guidance, training, and direction on technical items. Design and lead selection of process trains and process flows. Design and execute experiments to enhance process understanding and manufacture GMP batches at various scales. Responsible for the creation, management and control of systems and procedures including batch records, change controls and standard operating procedures for area of responsibility with a strong focus on efficiency and continuous improvement. Design and lead process development activities focused on developing well understood, science driven products and processes at all scales resulting in robust and repeatable control. Select appropriate parameters for prototype/finished dosage production to ensure product quality and reproducibility are achieved. Managing a systematic approach to Process Development and Technology Transfer activities to ensure that consistency in, and quality of end processes developed is achieved. Preparation, review, and approval of protocols, reports and sections of regulatory submissions. Maintaining compliance with all aspects of cGMP, Safety and Environmental legislation and Company policy, which impacts on day-to-day activities. Present technical data to cross functional teams and senior management as a process development expert, and effectively communicate critical process issues and solutions. Manage, train and mentor junior Process Development staff.

Requirements: Bachelor’s Degree in Pharmaceutical Manufacturing, Chemical Engineering or a related field and ten years of experience in pharmaceutical solid oral dosage processing. Experience must include ten years each of the following: processing techniques including powder blending granulation, compression, and coating; small molecule process development, scale up and technical transfer; design of experiments, data analysis and data interpretation for process development studies; technical problem-solving utilizing research and technologies; drug development process; applying ICH, FDA, and USP guidelines in stages of drug development; and drug product formulation. Experience may be gained concurrently.

Salary: $165,000-$170,000/year

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